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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002941-23 | EudraCT Number |
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To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.
This multi-center study consisted of 2 parts: Part A and Part B. Only Part A is described in this record. Part A was a randomized, double-blind 21-day treatment study period. Participants were randomized to one of 3 doses of active drug or placebo at a 4:1 ratio.
Participants who satisfied all inclusion and none of the exclusion criteria were assigned a unique participant number and then began a 28-day baseline observation period.
Eligible participants were then randomly assigned to receive one of 3 dose levels of GWP42003-P: 5 milligrams (mg) per kilogram (kg) per day, 10 mg/kg/day, 20 mg/kg/day, or matching placebo.
There were three groups of ten participants. In each group, participants were randomly assigned so that eight participants received active treatment and two participants received placebo. Participants received GWP42003-P or placebo for a 21-day exposure period, which consisted of a titration period, followed by a stable dose period.
A PK assessment took place after the first single dose of GWP42003-P. There was a second PK assessment after 21 days of consecutive dosing with GWP42003-P. Participants who took clobazam (CLB) as an adjunctive treatment were asked to take their usual dose 2 hours prior to attending the clinic. The same recommendation was made for other concomitant antiepileptic drugs (AEDs), if applicable. This was so that the pre-treatment (with GWP42003-P) plasma concentrations of CLB, its major metabolite N-desmethylclobazam, and any other concomitant AEDs could be measured, and the impact of GWP42003-P treatment on these levels evaluated. Interim clinic visits to (primarily) evaluate safety and adherence to the titration regimen took place at 7 and 14 days of treatment.
After 21 days of treatment, all participants commenced a 10-day down-titration taper period. An independent Data Safety Monitoring Committee reviewed unblinded safety and PK data and recommended the target dose (up to 20 mg/kg/day) for Part B of the study and for an open label extension study. Once the safety review of Part A data had taken place, participants had the option of entering the open label extension study.
A follow-up telephone call was made 28 days after the end of dosing for participants who did not enter the open label extension study within this time-frame.
Throughout the 21-day treatment period and the 10-day taper period, there were regular safety telephone calls (approximately every 2 days) to check participant status. Weekly safety telephone calls were made during the 28-day follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42003-P 5 mg/kg/day Dose | Experimental | Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
|
| GWP42003-P 10 mg/kg/day Dose | Experimental | Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
|
| GWP42003-P 20 mg/kg/day Dose | Experimental | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
|
| Placebo | Placebo Comparator | Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWP42003-P 5 mg/kg/day Dose | Drug | GWP42003-P was an oral solution containing 25 mg/milliliter (mL) cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module. | Baseline (Day 1) through Safety follow-up visit (Day 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 | AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33155 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29540584 | Background | Devinsky O, Patel AD, Thiele EA, Wong MH, Appleton R, Harden CL, Greenwood S, Morrison G, Sommerville K; GWPCARE1 Part A Study Group. Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology. 2018 Apr 3;90(14):e1204-e1211. doi: 10.1212/WNL.0000000000005254. Epub 2018 Mar 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GWP42003-P 5 mg/kg/Day Dose | Participants received GWP42003-P 5 milligrams (mg) per kilogram (kg) per day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Placebo control | Drug | Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). |
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| GWP42003-P 10 mg/kg/day Dose | Drug | GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day. |
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| GWP42003-P 20 mg/kg/day Dose | Drug | GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day. |
|
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| Predose and 2-6 hours postdose on Days 1 and 22 |
| Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations | Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22). | Predose on Days 1 and 22 |
| Atlanta |
| Georgia |
| 30328 |
| United States |
| Chicago | Illinois | 60611 | United States |
| Iowa City | Iowa | 52242 | United States |
| Boston | Massachusetts | 02114 | United States |
| Winston-Salem | North Carolina | 27408 | United States |
| Columbus | Ohio | 43205 | United States |
| Houston | Texas | 77030 | United States |
| Edinburgh | EH9 1LF | United Kingdom |
| Liverpool | L12 2AP | United Kingdom |
| London | WC1N 3JH | United Kingdom |
| FG001 | GWP42003-P 10 mg/kg/Day Dose | Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| FG002 | GWP42003-P 20 mg/kg/Day Dose | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| FG003 | Placebo | Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. |
| Safety Analysis Set | All randomized participants who received at least 1 dose of IMP |
|
| COMPLETED |
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| NOT COMPLETED |
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| Taper Period |
|
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Safety Analysis Set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
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| ID | Title | Description |
|---|---|---|
| BG000 | GWP42003-P 5 mg/kg/Day Dose | Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| BG001 | GWP42003-P 10 mg/kg/Day Dose | Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| BG002 | GWP42003-P 20 mg/kg/Day Dose | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| BG003 | Placebo | Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module. | Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set. | Posted | Count of Participants | Participants | Baseline (Day 1) through Safety follow-up visit (Day 60) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 | AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation. | Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanograms/mL | Predose and 2-6 hours postdose on Days 1 and 22 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations | Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22). | Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set. | Posted | Number | percent change | Predose on Days 1 and 22 |
|
Up to Day 60
All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GWP42003-P 5 mg/kg/Day Dose | Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. | 1 | 10 | 8 | 10 | ||
| EG001 | GWP42003-P 10 mg/kg/Day Dose | Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. | 2 | 8 | 5 | 8 | ||
| EG002 | GWP42003-P 20 mg/kg/Day Dose | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. | 1 | 9 | 7 | 9 | ||
| EG003 | Placebo | Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. | 1 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Parvovirus Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Accident | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (17.0) | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (17.0) | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Urine ketone body absent | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Abnormal behaviour | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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Analytical issues for 7-OH-CBD related to reference material batch used during analysis. Data are qualitative.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Enquires | GW Research Ltd. | medinfo@gwpharm.com, medinfo@greenwichbiosciences.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004831 | Epilepsies, Myoclonic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004829 | Epilepsy, Generalized |
| D000073376 | Epileptic Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Lost to Follow-up |
|
| Male |
|
Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| OG002 | GWP42003-P 20 mg/kg/Day Dose | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
|
|
| OG002 | GWP42003-P 20 mg/kg/Day Dose | Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. |
| OG003 | Placebo | Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. |
|
|